Low profile introducer apparatus

Abstract

An introducer apparatus includes an outer sleeve and an inner cannula received within the lumen of the outer sleeve. The outer sleeve has a profile such that at least a portion of the distal end of the outer sleeve tapers in the distal direction at an angle not exceeding about 2° relative to a longitudinal axis of the apparatus. The distal open end of the outer sleeve has a wall thickness not exceeding about 0.003 inch, and is sized such that a first wire guide is receivable therethrough. The inner cannula includes a tapered distal end portion. The inner cannula distal open end is sized such that a second wire guide is receivable therethrough, and the first wire guide is not receivable therethrough. The tapered distal portion of the inner cannula extends distal to the distal open end of the outer sleeve, such that a generally smooth diametrical transition is provided between the outer sleeve tapered portion and the open distal end of the inner cannula.

The invention claimed is: 
     
       1. An introducer apparatus, comprising:
 an outer sleeve having proximal and distal open ends, and having a lumen extending longitudinally therethrough, said outer sleeve having a profile such that at least a portion of said outer sleeve tapers toward said outer sleeve distal end at an angle not exceeding about 2° relative to a longitudinal axis of the apparatus, said outer sleeve having a distal open end sized such that a first wire guide is receivable therethrough, said distal open end of said outer sleeve having a wall thickness not exceeding about 0.003 inch; and 
 an inner cannula having proximal and distal open ends, and having a lumen extending longitudinally therethrough, said inner cannula sized to be received within the lumen of said outer sleeve, said inner cannula having a portion that tapers toward the inner cannula distal end, said inner cannula distal open end sized such that a second wire guide is receivable through said inner cannula distal open end and said first wire guide is not receivable through said inner cannula distal open end, said tapered distal portion of said inner cannula extending distal to the distal open end of said outer sleeve and having a profile such that a generally smooth and gradual diametrical transition is provided from the outer sleeve tapered portion and through said inner cannula open end; and 
 wherein the greatest radial extent of the inner cannula is less than the inner diameter of the outer sleeve. 
 
     
     
       2. The apparatus of  claim 1 , wherein said outer sleeve tapered portion comprises between about the distal 5 and 50 mm of said outer sleeve. 
     
     
       3. The apparatus of  claim 2 , wherein said outer sleeve tapered portion comprises between about the distal 8 and 20 mm of said outer sleeve. 
     
     
       4. The apparatus of  claim 3 , wherein said outer sleeve tapered portion comprises about the distal 15 mm of said outer sleeve. 
     
     
       5. The apparatus of  claim 1 , wherein said outer sleeve tapered portion is tapered at an angle of between about 0.5° and 2°. 
     
     
       6. The apparatus of  claim 5 , wherein said outer sleeve tapered portion is tapered at an angle between about 1° and 1.5°. 
     
     
       7. The apparatus of  claim 1 , wherein said distal open end of said outer sleeve has a wall thickness of between about 0.0005 and 0.0015 inch. 
     
     
       8. The apparatus of  claim 7 , wherein said distal open end of said outer sleeve has a wall thickness of about 0.001 inch. 
     
     
       9. The apparatus of  claim 1 , wherein said outer sleeve has an outer diameter not exceeding about 6 French. 
     
     
       10. The apparatus of  claim 9 , wherein said outer diameter is between about 4 and 6 French. 
     
     
       11. The apparatus of  claim 10 , wherein said diameter is about 5 French. 
     
     
       12. An introducer kit comprising:
 a hollow thinwall needle, said needle having an outer diameter that does not exceed about 21 gauge (0.032 inch; 0.81 mm), and an inner diameter that does not exceed about 0.018 inch (0.46 mm); 
 a first wire guide, said first wire guide having an outer diameter not less than about 0.035 inch (0.89 mm); 
 a second wire guide, said second wire guide receivable in a bore of said needle; 
 an outer sleeve, said outer sleeve having proximal and distal open ends and having a lumen extending longitudinally therethrough, said outer sleeve having a profile such that a distal portion of said outer sleeve tapers toward said outer sleeve distal end at an angle not exceeding about 2° relative to a longitudinal axis of the apparatus, said outer sleeve tapered portion comprising between about the distal 8 and 20 mm of said outer sleeve, said outer sleeve having an outer diameter that does not exceed about 6 French and having a distal open end sized such that said first wire guide is receivable therethrough, said distal end of said outer sleeve having a wall thickness between about 0.0005 and 0.0015 inch; and 
 an inner cannula, said inner cannula having proximal and distal open ends and having a lumen extending longitudinally therethrough, said inner cannula sized to be received within the lumen of said outer sleeve, said inner cannula having a portion that tapers toward the inner cannula distal end, said inner cannula distal open end sized such that said second wire guide is receivable through said inner cannula open end and said first wire guide is not receivable through said inner cannula open end, said tapered distal portion of said inner cannula extending distal to the distal open end of said outer sleeve and having a profile such that a generally smooth and gradual diametrical transition is provided from the outer sleeve tapered portion and through said inner cannula open end; and 
 wherein the greatest radial extent of the inner cannula is less than the inner diameter of the outer sleeve. 
 
     
     
       13. The kit of  claim 12 , wherein said outer sleeve tapered portion comprises the distal 15 mm of said outer sleeve. 
     
     
       14. A method of inserting a wire guide into a body vessel of a patient for use in introducing a medical interventional device, comprising:
 providing an introducer system, said system comprising an introducer needle having an outer diameter that does not exceed about 21 gauge (0.032 inch; 0.81 mm) and an inner diameter that does not exceed about 0.018 inch (0.46 mm); a first wire guide having an outer diameter not less than about 0.035 inch (0.89 mm); a second wire guide having an outer diameter not greater than about 0.018 inch (0.46 mm) and being receivable in a bore of said introducer needle; and an introducer apparatus comprising an outer sleeve and an inner cannula, said inner cannula removably received in a lumen of said outer sleeve, said outer sleeve having proximal and distal open ends and a profile such that a distal portion of said outer sleeve tapers toward said sleeve distal end at an angle not exceeding about 2° with a longitudinal axis of the sleeve, said outer sleeve distal open end sized such that said first wire guide is receivable therethrough, said inner cannula having proximal and distal open ends and a lumen extending therethrough, and having a portion that tapers toward the inner cannula distal end, said inner cannula distal open end sized such that said second wire guide is receivable therethrough and said first wire guide is not receivable therethrough, said tapered distal portion of said inner cannula extending distal to the distal open end of said outer sleeve and having a profile such that a generally smooth and gradual diametrical transition is provided from the outer sleeve tapered portion and through said inner cannula open end; and 
 wherein the greatest radial extent of the inner cannula is less than the inner diameter of the outer sleeve; 
 injecting said needle into said body vessel; 
 guiding said second wire guide through said needle bore such that a distal end of said wire guide extends beyond said needle in said body vessel; 
 withdrawing said needle from said body vessel over said second wire guide; 
 introducing said introducer apparatus over said second wire guide such that the respective distal ends of said outer sleeve and inner cannula are in said body vessel, wherein said introducing step comprises inserting said distal end of said inner cannula into said body vessel at a first insertion force, and inserting said introducer apparatus at a juncture of said outer sleeve distal open end and said inner cannula at a second insertion force, such that said second insertion force does not exceed said first insertion force; 
 withdrawing said second wire guide from said introducer apparatus while maintaining the introducer apparatus in the body vessel; 
 separating the inner cannula from the outer sleeve, and removing the inner cannula while maintaining the outer sleeve in the body vessel; and 
 guiding said first wire guide through said outer catheter such that a distal end of said first wire guide extends beyond said outer sleeve in said body vessel. 
 
     
     
       15. The method of  claim 14 , further comprising:
 withdrawing said outer cannula over said first wire guide. 
 
     
     
       16. The method of  claim 14 , wherein said angle is about 1°. 
     
     
       17. The method of  claim 16 , wherein said distal open end of said outer catheter has a thickness less than about 0.003 inch. 
     
     
       18. The method of  claim 16 , wherein said distal open end of said outer catheter has a thickness of about 0.001 inch. 
     
     
       19. The apparatus of  claim 1 , wherein said apparatus is structured such that an insertion force required for insertion of said apparatus through a body vessel at a juncture of said outer sleeve distal open end and said inner cannula does not exceed an insertion force required for an initial insertion of a distal end of said inner cannula through said body vessel. 
     
     
       20. The apparatus of  claim 1 , wherein said apparatus is structured such that a lesser insertion force is required for insertion of said apparatus through a body vessel at a juncture of said outer sleeve distal open end and said inner cannula than is required for an initial insertion of a distal end of said inner cannula through said body vessel.